A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease

This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: Comprehensive Self-Management Intervention; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthcare provider diagnosis of inflammatory bowel disease
• Report current symptoms
• Able to read and write in English

Exclusion Criteria:

• Live outside of Washington state
• Bowel-related surgery within the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive Self-Management; The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.	Behavioral: Comprehensive Self-Management Intervention; In addition to standard care, participants receive content on self-management which includes cognitive behavioral therapy, relaxation, and diet. Weekly phone calls provide support for achieving the sessions goals.
Other: Usual care group; The control group will receive standard care without the comprehensive self-management intervention.	Other: Control; The control group will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Percentage comprised of number of participants enrolled divided by the number of participants approached.	From screening to enrollment
Intervention feasibility	Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5).	3 months
Acceptability	A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Short Inflammatory Bowel Disease Questionnaire is a 10-item questionnaire which evaluates quality of life. Participants respond on a 7-item Likert scale from all the time to none of the time. Total score range: 10 to 70.	Baseline, 3 months, 6 months
Change in Symptoms	Symptoms are measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10). Symptoms include: abdominal pain, anxiety, bloating, constipation, depressed, diarrhea, fatigue/tiredness, passing gas, sleepiness during the day, stress, and urgency.	Baseline, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy for Managing Chronic Disease	a 6-item self-report scale. Participants report ranging from not at all confident to totally confident.	Baseline, 3 months, 6 months
Index of Self-Regulation	a 9-item scale to measure individual's level of self-regulation	Baseline, 3 months, 6 months
Patient Activation Measure	a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health	Baseline, 3 months, 6 months
Fecal Calprotectin	Level of fecal calprotectin assessed using ELISA.	Baseline, 3 months
Gut Microbiome	Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York)	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Kendra Kamp, PHD, RN, University of Washington

Publications and helpful links

General Publications

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
• Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy RL, Dey N, Lee S, Keefer L, Heitkemper M. A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 7;12:e46307. doi: 10.2196/46307.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: IBD; CD; UC
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: STUDY00015210; 1K23NR020044-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No